NCT05653843

MANTIS Endoscopic Clipping Study

Completed Results posted Last updated 12 August 2025

What this trial tests

trial testing Endoscopic clip placement in the gastrointestinal tract. in Hemostasis in 240 participants. Completed in 7 August 2024.

Timeline

28 March 2023

Primary endpoint
7 August 2024

7 August 2024

Quick facts

Lead sponsor	Boston Scientific Corporation
Status	Completed
Study type	OBSERVATIONAL
Enrollment	240
Start date	28 March 2023
Primary completion	7 August 2024
Estimated completion	7 August 2024
Sites	10 locations across Hong Kong, Japan, Canada, China, United States, India

Drugs / interventions tested

• Endoscopic clip placement in the gastrointestinal tract.

Conditions studied

• Hemostasis — all drugs for Hemostasis →
• Perforation Colon — all drugs for Perforation Colon →
• Feeding Tube Complication — all drugs for Feeding Tube Complication →
• Endoscopy — all drugs for Endoscopy →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

Eligibility, any sex, with Hemostasis or Perforation Colon. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Hemostasis of Active Bleeding Primary · Index Procedure

Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure

Group	Value	95% CI
MANTIS Clipping Study	239

Number of Participants With Prophylactic Hemostasis Primary · Up to 30 Days after the index clipping procedure

Clinical success defined as hemostasis as a prophylactic measure to minimize risk of a delayed bleeding post lesion resection, defined as absence of a bleeding SAE up to 30 days after the index clipping procedure

Group	Value	95% CI
MANTIS Clipping Study	164

Number of Lesions With Defect Closures Primary · Index Procedure

Clinical success defined as defect closure

Group	Value	95% CI
MANTIS Clipping Study	4

Number of Participants With Serious Adverse Events Primary · Up to 30 Days after the Endocsopic clipping procedure

Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure

Group	Value	95% CI
MANTIS Clipping Study	10

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 36 days post index procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MANTIS Clipping Study

Serious: 14/240 (6%)

Deaths: 1/240

Serious adverse events (14 terms)

Reaction	System	MANTIS Clipping Study
Caecal perforation	Gastrointestinal disorders	—
Death - Worsening sepsis	Gastrointestinal disorders	—
Aspiration	Gastrointestinal disorders	—
Diverticular bleed - site unknown	Gastrointestinal disorders	—
GI Mucosal injury	Gastrointestinal disorders	—
Intrasubmucosal leak	Gastrointestinal disorders	—
Ischemia colitis	Gastrointestinal disorders	—
Left lower abdominal pain	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Ongoing lower GI bleeding	Gastrointestinal disorders	—
Pneumoperitoneum	Gastrointestinal disorders	—
Post EMR lower GI Bleeding	Gastrointestinal disorders	—
Post-Polypectomy Syndrome	Gastrointestinal disorders	—
Septic shock	Gastrointestinal disorders	—

Most-reported serious reactions: Caecal perforation, Death - Worsening sepsis, Aspiration, Diverticular bleed - site unknown, GI Mucosal injury, Intrasubmucosal leak, Ischemia colitis, Left lower abdominal pain.

Data from ClinicalTrials.gov NCT05653843 adverse events section.

Sponsor's own description

This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited to hemostasis, closure, anchoring and marking.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. High Rates of Defect Closure After Resection of Large Nonpedunculated Colorectal Lesions Using a Through-The-Scope Clip With Anchor Prongs.
   von Renteln D, Rex DK, Pohl H, Kumta NA, et al · · 2026 · cited 1× · PMID 41442239 · DOI 10.1002/ueg2.70164
2. Through-the-scope clip with anchor prongs for defect closure following myotomy, resection, anti-reflux mucosectomy, fistula management, or bleeding.
   Mosko JD, Al-Haddad M, Pohl H, Kumta NA, et al · · 2026 · PMID 41988030 · DOI 10.1055/a-2773-4910
3. A28 PROFILE OF ACTIVATED B-CELL EXPANSION IN THE DISTAL COLON AND MESENTERIC LYMPH NODES OF COLITIC MICE
   · 2025
4. A26 PROFILE OF ACTIVATED B-CELL EXPANSION IN THE DISTAL COLON AND MESENTERIC LYMPH NODES OF COLITIC MICE
   · 2025
5. A30 THROUGH-THE-SCOPE CLIP WITH ANCHOR PRONGS FOR PROPHYLACTIC CLIP CLOSURE AFTER GI LESION RESECTION: A PROSPECTIVE COHORT STUDY
   · 2025
6. A29 A NOVEL INTERACTIVE COMPLEX BETWEEN TP53, SIRT1 AND HNF4A2 IN INTESTINAL EPITHELIAL CELLS
   · 2025
7. A27 THE IMPACT OF MICROBIAL-DERIVED METABOLITES ON TYPE III INTERFERON SIGNALING IN INTESTINAL EPITHELIAL CELLS
   · 2025